Introducer support for a catheter positioning system

ABSTRACT

Various embodiments enable an introducer for a catheter to be rotated around an axis and/or traversed backward and/or forward along the axis. In various embodiments, positioning of an introducer may be enabled by an introducer support configured to be rotated around an axis and/or extended or retracted along the axis. The introducer may be manually operated and/or operated by motors in a nose cone of a catheter positioning system. In various embodiments, a portion of the introducer support may be configured to flex. In other embodiment, positioning of an introducer may be enabled by an adjustable nose cone of a catheter positioning system.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention is a divisional application of U.S. applicationSer. No. 14/478,711 entitled “ADJUSTABLE NOSE CONE FOR A CATHETERPOSITIONING SYSTEM” filed Sep. 5, 2014, now U.S. Pat. No. 9,999,751which claims the benefit of priority to U.S. Provisional PatentApplication No. 61/874,439, entitled “ADJUSTABLE NOSE CONE FOR ACATHETER POSITIONING SYSTEM,” filed Sep. 6, 2013, the entire contents ofboth of which are incorporated herein by reference.

BACKGROUND

Many procedures involving catheter insertion, such as invasiveelectrophysiology procedures, rely on fluoroscopy or other radioactiveimaging techniques to help navigate and position the catheter within apatient's body at a particular site, such as in the heart or inside ablood vessel in the circulatory system. High dosages of radiation canhave long term adverse health effects. A patient may be directly exposedonly once or twice to radiation during such procedures and avoid suchadverse effects. However, physicians, medical technicians and staff canexperience a large cumulative radiation dosage over time, both directlyand indirectly, from conducting many procedures.

To protect the operator and staff from this radiation, shielding such aslead aprons, gowns, glasses, skirts, etc., is worn. Such lead clothing,especially a lead apron, is quite heavy and uncomfortable, and its usehas been associated with cervical and lumbar spine injury ordegradation.

SUMMARY OF THE INVENTION

Various embodiments enable a catheter introducer for use on a catheterpositioning system to be rotated around an axis and/or traversedbackward and/or forward along the axis. In various embodiments,positioning of an introducer may be enabled by an introducer supportconfigured to be rotated around an axis and/or extended or retractedalong the axis. The introducer may be manually operated and/or operatedby motors in a nose cone of the catheter positioning system. In otherembodiment, positioning of an introducer may be enabled by an adjustablenose cone of the catheter positioning system.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate exemplary embodiments of theinvention, and together with the general description given above and thedetailed description given below, serve to explain the features of theinvention.

FIG. 1 is a system block diagram illustrating a remote controller, aremotely controlled catheter positioning system, and a programmablecontrol system.

FIG. 2 is a diagram illustrating an oblique view of a catheter bodythreaded through an introducer.

FIG. 3 is a diagram illustrating an oblique view of an embodimentadjustable introducer support.

FIG. 4 is a component diagram illustrating an embodiment adjustableintroducer support and nose cone portion.

FIG. 5A is a diagram illustrating a cut away view of an embodimentadjustable nose cone.

FIG. 5B is a diagram illustrating a cross sectional view of theembodiment adjustable nose cone shown in FIG. 5A.

FIG. 5C is a diagram illustrating an oblique view of the rear of theembodiment adjustable nose cone of FIG. 5A.

FIG. 6 is a diagram illustrating an oblique view of an embodimentadjustable nose cone with a removable linkage.

FIG. 7 is a diagram illustrating an oblique view of an alternateembodiment adjustable nose cone with a removable linkage.

FIG. 8A is a diagram illustrating an oblique view of an alternateembodiment adjustable nose cone and a reflection of the underside of theadjustable nose cone.

FIG. 8B is a diagram illustrating another oblique view of the adjustablenose cone of FIG. 8A.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.References made to particular examples and implementations are forillustrative purposes and are not intended to limit the scope of theinvention or the claims.

The systems, methods, and devices of the various embodiments enable acatheter introducer for use on a catheter positioning system to berotated around an axis and/or traversed backward and/or forward alongthe axis. The catheter positioning system enables a physician toremotely control manipulation and insertion of a catheter into a patientwhile being positioned away from sources of radiation used for imagingor other procedures. The introducer is a component of a catheterpositioning system that introduced the catheter into a patient's body,and thus is a structure that contacts both the patient and the catheterpositioning system. The catheter positioning system may be used to movethe attached catheter through the introducer, and thus within thepatient, such as rotating, advancing, or retracting the catheter inrelation to the patient or within the patient's body. An example of acatheter positioning system is disclosed in PCT ApplicationPCT/US2009/031357, which published as WO 2009/092059 and is incorporatedherein by reference in its entirety.

The introducer is positioned on the catheter positioning system so thata catheter body passes through the introducer to enter a patient's body.The various embodiments enable the introducer to be rotated throughvarious angles and/or to be moved into and out of a patient variousdistances in order to direct the shaft of the catheter in a particulardirection and/or to a particular spot within the patient. Such movementor repositioning of the introducer can resolve problems that may ariseduring a catheterization procedure, particularly for certain catheters.

During an operation, a physician may wish to manually control theintroducer rather than remotely controlling the introducer with thecatheter positioning system. Various embodiments may enable theintroducer to be easily removed from the catheter positioning system bythe physician to enable such manual manipulation. The removableintroducer may remain connected with an introducer support when removedfrom the catheter positioning system, and may enable the introducer tobe easily reconnected to the catheter positioning system by thephysician.

In various embodiments, positioning of an introducer may be enabled byan introducer support configured to be rotated around an axis and/orextended or retracted along the axis. The introducer support may bemanually operated and/or operated by motors in a nose cone of thecatheter positioning system. In various embodiments, a portion of theintroducer support may be made from flexible materials or otherwiseconfigured to flex. In other embodiment, positioning of an introducermay be enabled by an adjustable nose cone of the catheter positioningsystem.

FIG. 1 illustrates an embodiment catheter positioning system 100 with aremote controller 124 and a programmable control system 132. Thecatheter positioning system 100 may further include a sled base 102coupled with a sled member 104. The sled base 102 may be configured witha drive unit, such as a drive unit 111, to advance or to facilitateadvancing the sled member 104 along the sled base 102 towards the bodyof the patient or back away from the patient. For example, the sledmember may be moved with a motor (not shown) in the drive unit 111 atone end of the sled base 102. The sled member 104 may be driven along arail on the sled base 102 by a drive mechanism (not shown) in the driveunit 111, such as a worm drive, in order to advance or withdraw acatheter (not shown), which may be coupled to the sled member 104 or toa component that is coupled to the sled member 104.

The sled base 102 may be held in position above a patient and/or anoperating table 120 by a bridge (not shown) or support arm 112. Thesupport arm 112 may be coupled to a sled base support structure 114through articulating joints. When moved into a working position, thesled base support structure 114 hold the sled base 102 in a fixedposition and orientation. The arm 112 and the sled base supportstructure 114 may further be extended or rotated to position the sledbase 102 relative to a patient on the operating table 120. The sled base102 may also include a nose cone coupled to an introducer 116 thatsupports insertion of the catheter into a patient. The sled base 102and/or nose cone may include one or more motors which may drive one ormore actuators, such as gears, to change a position/orientation of theintroducer 116, thereby allowing an operator to control theposition/orientation of the introducer 116 via the remote controller124. A catheter may be advanced along the sled base 102 by the sledmember 104 so that the body of the catheter passes through the nose coneand introducer 116 and into the patient.

The sled base 102 may include a sterile barrier (not shown) configuredto support and protect the catheter. The sterile barrier may include aresealable delivery channel configured to receive and guide the catheteralong the sled base as it is advanced by the sled member 104. Forexample, the body of the catheter may be inserted into the deliverychannel and then the catheter handle 118 may be connected to the sledmember 104 (such as by using the modular plate 106 discussed below) suchthat the catheter body is driven forward by translation of the sledmember 104 along the resealable delivery channel in the sled base 102and through the nose cone and introducer 116 into the patient.

The sled member 104 may be equipped with a modular plate 106 to which acatheter handle 118 may be attached. The modular plate 106 may beconfigured to be removable such that many alternative modular plates106, may be swapped in and out. Thus, the catheter positioning systemmay be used with many different types of catheters by the use of acorresponding modular plate 106, such as alternative plates that areadapted for use with alternative catheters or catheter handles.Depending on the kind of catheter that is desired for a given procedure,an appropriate modular plate 106 may be attached to the sled member 104and the catheter and/or the catheter handle 118 may be attached to themodule plate 106. The modular plate 106 may integrate with any actuatorson the catheter handle 118, thereby allowing an operator to control theactuators via the remote controller 124.

The sled member 104 may be rotated by a drive mechanism 110 in order torotate a catheter connected to the modular plate 106. The rotation ofthe sled member 104, such as by actuating the drive mechanism 110, maybe controlled remotely via the remote controller 124. By controllingtranslation along the sled base 102, the rotation of the sled member104, and the actuation of the catheter's handle via the modular plate106, an operator may position or use the catheter in any way necessaryfor a desired operation. Further, an operator may control each of thesedegrees of freedom (i.e., translation, rotation, and actuation) remotelywith the remote controller 124.

A remote controller 124 may be connected to a system processor of theprogrammable control system 132 by one or more of a wired connector 136or a wireless data link (not shown), such as a Bluetooth link. Thesystem processor of the programmable control system 132 may also beconnected to the catheter positioning system 100 and the various motorswithin the catheter positioning system 100, such as nose cone motors,sled motors, sled base motors, etc., by one or more wired connector 134a or a wireless data link 134 b. The system processor of theprogrammable control system 132 may output control signals to actuatethe motors of the catheter positioning system 100 based on inputs fromthe remote controller 124 and/or based on a calibration sequence, atraining sequence or a programming sequence, such as programmedmovements for automatic positioning of the catheter. Programmedmovements of the catheter positioning system 100 may be input prior to amedical procedure, such as by entering commands into the systemprocessor of the programmable control system 132 (e.g., via a keyboard)or by calibrating and/or training the system, such as throughmanipulation of the remote controller 124, selection of other real-timeoperations from the programmable control system 132, and so on. Inparticular, the programmable control system 132 may be configured withprocessor-executable instructions to issue drive or power commands toeach of the motors in the catheter positioning system 100 to control therelative rotations of each motor to rotate the introducer 116 about anaxis and/or traverse the introducer 116 backward or forward along theaxis.

The system processor of a programmable control system 132 may beimplemented or performed with a general purpose processor, a digitalsignal processor (DSP), an application specific integrated circuit(ASIC), a field programmable gate array (FPGA) or other programmablelogic device, discrete gate or transistor logic, discrete hardwarecomponents, or any combination thereof designed to perform the functionsdescribed herein. A general-purpose processor may be a microprocessor,but, in the alternative, the processor may be any conventionalprocessor, controller, microcontroller, or state machine. A processormay also be implemented as a combination of computing devices, e.g., acombination of a DSP and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with a DSPcore, or any other such configuration. Alternatively, some operationsmay be performed by circuitry that is specific to a given function.

FIG. 2 illustrates a catheter 202 assembly having portions that passthrough an introducer 208. The body 206 of the catheter 202 may extendfrom the handle 204 of the catheter 202 toward the introducer 208. Theintroducer 208 may include a throat 214 connected to a sheath 212. Thethroat 214 and sheath 212 may form a hollow passage through which thebody 206 of the catheter 202 may pass. The introducer 208 may alsoinclude one or more irrigation port 210 configured to enable fluids tobe passed through the irrigation port 210 into and/or out of the throat212 and/or sheath 212. The introducer 208 may guide the body 206 of thecatheter 202 into/out of a patient's body, such as at a catheterinsertion site. The introducer 208 may further provide mechanicalsupport and protection against buckling or bending of the body 206 ofthe catheter 202 as the body 206 of the catheter 202 is advanced,retracted, and/or held stationary through the introducer 208.

While illustrated as a straight tube with a straight tip, the sheath 212of the introducer 208 may have other shapes, such as a curved, angled,preformed tip, etc. Additionally, the length of the sheath 212 of theintroducer 208 illustrated in FIG. 2 is not to scale and is providedmerely as an illustration. The sheath 212 of the introducer 208 may havedifferent lengths. The introducer 208 may be rotated at various anglesand/or may be moved into and out of a patient various distances todirect the shaft 206 of the catheter 202 in a particular directionand/or to a particular spot within the patient. As an example, anintroducer 208 with an angled tip may be moved forward and rotated toposition a tip of the shaft 206 of the catheter 202 behind an organ in apatient's body. As discussed above, the introducer 208 may be held in anose cone of the catheter positioning system 100. In an embodiment, theintroducer 208 may be held in a nose cone by an introducer clamp whichmay fasten over a portion of the throat 214 of the introducer 208. Inanother embodiment, the introducer 208 may include threads within thethroat 214 and may screw onto a threaded portion of a nose cone.

FIG. 3 illustrates an introducer support 302 which may be connectedbetween a nose cone and an introducer 208 to enable the introducer 208to be rotated through an angle R′ around an axis A and/or to be extendedor retracted a distance D′ along the axis A. The introducer support 302may also include a flexible section or flex structure configured to flexto enable the introducer 208 to move in response to a force exerted onthe introducer 208 while connected to the introducer support 302. Suchflexure may reduce pressures applied to the patient at the point ofentry of the introducer due to movement of the patient and/or thecatheter positioning system. The introducer support 302 may include ahollow outer cylindrical body 312 encircling a hollow central shaft 314.

The outer cylindrical body 312 may be configured to slide over thecentral shaft 314 to rotate through an angle R around the central shaft314 and axis A and to extend or retract a distance D along the centralshaft 314 and axis A. In some embodiments, the outer cylindrical body312 may rotate about the central shaft 314. For example, in someembodiments, the outer cylindrical body 312 may rotate 360 degreesclockwise or counterclockwise around the central shaft 314 and axis A.In an embodiment, an end of the outer cylindrical body 312 may traversea distance of between about 1 inch and about two inches and preferablyabout 1.5 inches in one direction along the axis A to move from a fullyretracted to a fully extended position and may traverse a distance ofbetween about 1 inch and about two inches and preferably about 1.5inches in the opposite direction along the axis A to move from the fullyextended position to the fully retracted position.

The introducer support 302 may be attached to a clamp 304 of a nose coneof a catheter positioning system by a friction or a snap fit. The clamp304 may fasten over an attachment end 316 of the central shaft 314 ofthe introducer support 302 to securely hold the central shaft 314 of theintroducer support 302 in place.

An end of the outer cylindrical body 312 opposite the attachment end 316may include an introducer clamp 310 formed from a fixed clamp portion311 extending from the outer cylindrical body 312 and a clamp tab 306rotationally coupled to the fixed clamp portion 311 by a hinge 308. Theclamp tab 306 may fasten to the fixed clamp portion 311 by friction or asnap fit and the resulting introducer clamp formed from the fixed clampportion 311 and clamp tab 306 may fasten over a throat 214 of anintroducer 208 to securely hold the introducer 208 in place. In someembodiments, the clamp tab 306 may include teeth or other adjustablegripping and/or tensioning mechanisms that allow the clamp tab 306 toclamp to different sizes or configurations of the throat 214.

In an embodiment, the fixed clamp portion 311 and/or the clamp tab 306may include cutouts configured to enable the irrigation port 210 of theintroducer to pass through the introducer clamp formed from the fixedclamp portion 311 and clamp tab 306.

A catheter body may pass through the clamp 304 the introducer support302 and the introducer 208 when the clamp 304, the introducer support302, and the introducer 208 are coupled together. The clamp 304 of thenose cone may be opened and the introducer support 302 and introducer208 may be removed from the nose cone as a single unit, thereby enablinga doctor or operator to manipulate the introducer support 302 andintroducer 208 independent of a catheter positioning system.

In an embodiment, the clamp 304, introducer support 302, and introducer208 may be coupled together and the outer cylindrical body 312 may beslid over the central shaft 314 and may directly or indirectly engagethe introducer 208 and the shaft 212, such as through the introducerclamp 310. As the outer cylindrical body 312 is rotated through an angleR around the central shaft 314 and axis A, a corresponding rotation maybe imparted to the shaft 212 of the introducer 208 to rotate the shaft212 a distance R′ around the axis A.

In an embodiment, the clamp 304, introducer support 302, and introducer208 may be coupled together and the outer cylindrical body 312 may beslid over the central shaft 314 and may directly or indirectly engagethe introducer 208 and the shaft 212, such as through the introducerclamp 310. As the outer cylindrical body 312 is extended or retracted adistance D along the central shaft 314 and axis A, a correspondingextension or retraction may be imparted to the shaft 212 of theintroducer 208 to extend or retract the shaft 212 a distance D′ alongthe axis A. In this manner, the introducer support 302 may be rotated tovarious angles and/or may be moved into and out of a patient variousdistances to direct the shaft 212 of the introducer 208 and/or a shaftof a catheter passed through the introducer support 302 and introducer208 in a particular direction and/or to a particular spot within thepatient.

In an embodiment, the outer cylindrical body 312 may include a flexibleportion 305 enabling the introducer clamp 310 (e.g., formed from thefixed clamp portion 311 and clamp tab 306 and the introducer 208) toflex in response to a force exerted on the introducer 208, such as forceresulting from the movement of a patient while the sheath 212 of theintroducer 208 is inserted in the patient. The flexible portion 305 maybe formed in any manner enabling the introducer clamp 310 (e.g., formedfrom the fixed clamp portion 311 and clamp tab 306 and the introducer208) to flex in one or more of the rotational direction or the lineardirection, such as relative to the outer cylindrical body 312. In otherwords, the flexible portion 305 may be configured with one or moreflexibility parameters, such as torsional flexibility, compressiveflexibility, and tensile flexibility. As an example, the flexibleportion 305 may comprise one or more bellows formed in the outercylindrical body 312. As another example, the flexible portion 305 maybe formed from an elastic material that is flexible or at least lessrigid than other portions of the outer cylindrical body 312. The lengthof the flexible portion 305 along the outer cylindrical body 312 and theaxis A may depend upon the desired amount of flexibility (i.e., thetotal deflection or displacement from a normal dimension) of theflexible portion 305. For example, longer lengths of the flexibleportion 305 may be more flexible and enable more flexible deflectioncompared to a shorter flexible portion 305. The ability of theintroducer support 302 to flex may reduce or minimize disruption inpatient comfort at the introducer site when a patient moves while thesheath 212 of the introducer 208 is inserted into the patient's body.Additionally, the ability of the introducer support 302 to flex mayfacilitate attaching the introducer 208 into the introducer clamp 310(e.g., formed from the fixed clamp portion 311 and clamp tab 306)because precise alignment between the introducer 208 and the clamp maynot be necessary to fit the introducer 208 in the clamp.

FIG. 4 illustrates an introducer support 400 and portion of a nose cone410 of a catheter positioning system to which the introducer support 408may be connected. The portion of the nose cone 410 is shown as arectangular block for ease of illustration. The portion of the nose cone410 and the nose cone 410 may take many shapes, examples of which areshown and described in greater detail in connection with other figures.The introducer support 400 may be coupled to the nose cone 410 and theintroducer 208. The introducer 400 may be configured to enable theintroducer 208 to be rotated through an angle R′ around an axis A and/orto be extended or retracted a distance D′ along the axis A.

The introducer support 400 may include a hollow rotating portion 406that encircles a hollow extending portion 404. The hollow rotationportion 406 may be configured to encircle the hollow extending portionin an inner circumferential cavity as the hollow extending portion 404extends or retracts along the axis A. The outer circumference of thehollow rotating portion 406 may include gear teeth formed from groovesand ridges running parallel to the axis A. The gear teeth may allow thehollow rotating portion 406 to be rotated about the axis A by a drivethat engages the gear teeth. The outer circumference of the hollowextending portion 404 may include a series of circumferential engagingmembers, such as a series of circumferential gear teeth formed from aseries of circular grooves and ridges running around the outercircumference of and along the length of the hollow extending portion404. Each ridge and groove may be oriented in a respective planeperpendicular to the axis A. The hollow extending portion 404 may beconfigured to slide into and/or out of the hollow rotating portion 406 adistance D along the axis A.

The hollow rotating portion 406 may be configured to contact orotherwise grip the hollow extending portion 404 such that when thehollow rotating portion 406 is rotated in either direction around theaxis A, a corresponding rotation in the same direction of rotation isimparted to the hollow extending portion 404.

In an embodiment, the hollow rotating portion 406 may rotate 360 degreesin either direction around the axis A.

In an embodiment, the hollow extending portion 404 may traverse adistance of between about 1 inch and about two inches and preferablyabout 1.5 inches in a first direction along the axis A to move from afully retracted to a fully extended position. The hollow extendingportion 404 may traverse a distance between about 1 inch and about twoinches and preferably about 1.5 inches in an opposite direction of thefirst direction along the axis A to move from the fully extendedposition to the fully retracted position.

The introducer support 400 may include a support extension 408rotationally coupled to the hollow rotating portion 406 and configuredto be secured in a clamp of the nose cone 410 of the catheterpositioning system by friction or a snap fit. As an example, a clamp mayfasten over the support extension 408 of the introducer support 400 tosecure the introducer support 400 in place.

An end of the hollow extending portion 404 opposite the supportextension 408 may include an introducer clamp formed from a fixed clampportion 402 extending from the hollow extending portion 404 and a clamptab (not shown) rotationally coupled to the fixed clamp portion 402 by ahinge (not shown). The clamp tab may fasten to the fixed clamp portion402 by friction or a snap fit and the resulting introducer clamp formedfrom the fixed clamp portion 402 and clamp tab may fasten over a throat214 of an introducer 208 to securely hold the introducer 208 in place.

In an embodiment, the fixed clamp portion 402 and/or the clamp tab mayinclude cutouts configured to enable the irrigation port 210 of theintroducer to pass through the introducer clamp formed from the fixedclamp portion 402 and clamp tab.

A catheter body may pass through the clamp, the introducer support 400and the introducer 208, such as when the clamp, introducer support 400,and introducer 208 are coupled together. The clamp of the nose cone 410securing the support extension 408 may be opened and the introducersupport 400 and introducer 208 may be removed from the nose cone 410 asa single unit, thereby enabling a doctor or operator to manipulate theintroducer support 400 and introducer 208 independent of a catheterpositioning system.

In an embodiment, in order to drive the hollow rotating portion 406, theportion of the nose cone 410 may include a first motor 412 coupled to afirst gear 414. The teeth of the first gear 412 may be configured tointerface with the gear teeth of the hollow rotating portion 406 whenthe introducer support 400 is secured in the nose cone 410. The firstgear 414 may interface with the gear teeth of the hollow rotatingportion 406 such that the motor 412 may turn the first gear 414, whichcauses the hollow rotating portion 406 to rotate. As discussed above,the hollow rotating portion 406 may be coupled to the hollow extendingportion 406 such that rotation of the hollow rotating portion 406 causesthe hollow extending portion 404 and the introducer 208 secured in theclamp of the hollow extending portion 404 to rotate. In this manner, therotation of the first gear 414 by the first motor 412 may rotate thehollow rotating portion 406 through an angle R around the axis A. Acorresponding rotation may be imparted to the shaft 212 of theintroducer 208 to rotate the shaft 212 through an angle R′ around theaxis A.

In some embodiments, a sensor 413 may be coupled to the first motor 412,such as to the motor driver circuit, to a data interface, to arotational shaft, or to a power line for the first motor 412. The sensor413 may be configured to detect an irregularity in the rotationalmovement of the first motor 412, such as a rotational irregularity, adrive current irregularity, or other drive irregularity in the motor 412that indicates that a potential physical obstruction to the rotationalmovement has been encountered, or that an error condition exists. Thedetection of an obstruction condition may be treated as a signal to stopthe movement of the motor 412 to avoid or prevent an undesirablecondition.

While the sensor 413 is described in connection with the motor 412,other positions and couplings of the sensor 413 are possible. Forexample, in other embodiments, sensors may be located at an interfacebetween the nosecone, or components of the nosecone, and the catheterpositioning system. Sensors may be located so that they are inelectrical series with any nosecone drive mechanism. Alternatively oradditionally, sensors may be located in the nosecone with a feedbackmechanism to the catheter positioning system. For example, the sensorsmay be simple low cost mechanisms, such as a limit switch. In such anembodiment, activation of the sensors may signal the catheterpositioning system that a specific deflection, rotation, pressure orother limit quantity has been reached. In more complex embodiments, thesensors may be force sensors that signal when a specific force has beenreached. The complexity and cost of the sensors may determine where thesensors are located. For example, expensive and/or complex sensors maybe positioned away from the nosecone, such as at or near the catheterpositioning system, or catheter positioning system interface. Cheaper,simpler sensors may be located on or within the nosecone itself and maybe disposable.

In an embodiment, in order to drive the hollow extending portion 404,the portion of the nose cone 410 may include a second motor 416 coupledto a second gear 418. The teeth of the second gear 418 may be configuredto interface with the gear teeth (e.g., circumferential ridges andgrooves) of the hollow extending portion 404 when the introducer support400 is secured in the nose cone 410. The second gear 418 may interfacewith the gear teeth of the hollow extending portion 404 such that themotor 416 may turn the second gear 418, which causes the hollowextending portion to move along the axis A. In some embodiments, thesecond gear 418 may act as a rack gear extending and/or retracting thehollow extending portion 404, and the introducer 208 secured in theclamp of the hollow extending portion 404, a distance D along the axis Atoward and/or away from the hollow rotating portion 406. In this manner,the rotation of the second gear 418 by the second motor 416 may extendor retract the hollow extending portion 404 a distance D along the axisA, causing a corresponding extension or retraction to be imparted to theshaft 212 of the introducer 208 to extend or retract the shaft 212 adistance D′ along the axis A.

In some embodiments, a sensor 417 may be coupled to the second motor416, such as to the motor driver circuit, to a data interface, to arotational shaft, or to a power line for the second motor 416. Thesensor 417 may be configured to detect an irregularity in the rotationalmovement of the second motor 417, such as a rotational irregularity, adrive current irregularity, or other drive irregularity in the secondmotor 417 that indicates that a potential physical obstruction to thelinear extension or retraction movement of the hollow extending portion404 has been encountered, or that an error condition exists. Thedetection of an obstruction condition by the sensor 417 may be treatedas a signal to stop the movement of the motor 416 to avoid or prevent anundesirable condition. While the sensor 417 is described in connectionwith the motor 416, other sensor positions and couplings are possible.

The activation of the first motor 412 and/or second motor 416 and theresulting rotation of the first gear 414 and/or second gear 418,respectively, may enable the introducer support 400 to be rotated atvarious angles and/or to be moved into and out of a patient variousdistances to direct the shaft 212 of the introducer 208 and/or a shaftof a catheter passed through the introducer support 400 and introducer208 in a particular direction and/or to a particular spot within thepatient remotely without directly manually interacting with theintroducer support 400.

In an embodiment, the hollow extending portion 404 may include aflexible portion 405 enabling the introducer clamp formed from the fixedclamp portion 402 and clamp tab and the introducer 208 to flex inresponse to a force exerted on the introducer 208, such as forceresulting from the movement of a patient while the sheath 212 of theintroducer 208 is inserted in the patient. The flexible portion 405 maybe formed in any manner enabling the clamp formed from the fixed clampportion 402 and clamp tab and the introducer 208 to flex. As an example,the flexible portion 405 may comprise one or more bellows formed in thehollow extending portion 404. As another example, the flexible portion405 may be formed from a flexible material or an elastic material thatis less rigid than other portions of the hollow extending portion 404.As discussed above, the length of the flexible portion 405 may dependupon the amount of flexibility or total the deflection that is desiredto prevent or reduce trauma to the patient and/or facilitate attachingthe introducer 208 into the clamp formed from the fixed clamp portion402 and clamp tab.

FIG. 5A, FIG. 5B, and FIG. 5C illustrate various views of an embodimentadjustable nose cone 500. FIG. 5A illustrates a cut away view of a nosecone 500 showing the various components of an embodiment of the nosecone 500 and including the relationship of the components of the nosecone 500, which are positioned outside the housing 508, to thecomponents that are positioned inside the housing 508. Although examplerelationships are shown, they are illustrative in nature and are notintended to be limiting. Other configurations are possible.

The nose cone 500 may include the housing 508, a sheath holder 502, andan outer cylinder 506. The nose cone 500 may further include aconcentric an inner cylinder 510, which is shown in the cross sectionalview of FIG. 5B. The sheath holder 502 may be supported within thehollow center of the inner cylinder 510. The inner cylinder 510 andsheath holder 502 may be supported within the hollow center of the outercylinder 506.

The inner cylinder 510 may rotate within the outer cylinder 506. Theinner cylinder 510 and the outer cylinder 506 may both be held in afixed position along the axis A by the housing 508 while still beingenabled to rotate around the axis A.

The sheath holder 502 may be hollow with a central passage 503 that acatheter body may pass through. The outer circumference of the sheathholder 502 may include threads 512. An end 505 of the sheath holder 502may be configured to support an introducer for a catheter, such asintroducer 208 discussed above. As examples, an introducer, such as theintroducer 208, may screw onto the end 505 of the sheath holder 502 ormay clamp onto the end 505 of the sheath holder 502. Pins 504 a and 504b may pass through the outer cylinder 506 and may extend into grooves514 a and 514 b (visible in FIG. 5B) in the surface of the sheath holder502.

An end of the outer cylinder 506 may be configured with a toothed gear518 positioned within the housing 508. An end of the inner cylinder 508may be configured with a toothed gear 520 positioned within the housing508. The toothed gear 518 may interface with a drive gear 514 and thetoothed gear 520 may interface with a drive gear 524.

FIG. 5B presents a cross sectional view of the nose cone 500 includingthreads 507 that may extend along an inner circumference of the innercylinder 510. The threads 507 may interface with the threads 512 of thesheath holder 502 and may rotationally engage the threads 512 to movethe sheath holder 502 back and forth along the A axis. FIG. 5B furtherillustrates the respective engagement between the drive gears 514, 524and the toothed gears 518, 520.

FIG. 5C illustrates a rear view of the nose cone 500. The nose cone 500may include attachment points 531 a and 531 b that may be used forcoupling the nose cone 500 to a catheter positioning system, such as viasnaps and/or friction, screw connectors, or other connection mechanism.The nose cone 500 may be coupled to a catheter positioning system atseveral points. For example, a first shaft 526 and a second shaft 516may extend from and may be configured respectively to drive the gear 524and the gear 514.

The first shaft 524 may interface with a motor of the catheterpositioning system, such as a motor in a sled base. Further, the secondshaft 516 extending from and configured to drive gear 514 may interfacewith another motor in the catheter positioning system, for exampleanother motor in the sled base. In other embodiments, the respectivemotors that drive the first and second shafts 526, 516 may be positionedin the nose cone 500. The second shaft 516 extending from gear 514 maybe rotated by a drive motor that may drive the rotation of the gear 514.

Rotation of the gear 514 may cause the toothed gear 518 of the outercylinder 506 to rotate the outer cylinder 506 around the axis A. Therotation of the outer cylinder 506 around the axis A may cause the pins504 a and 504 b to rotate and to exert force against the sides of thegrooves 514 a and 514 b of the sheath holder 502 to rotate the sheathholder 502 in a direction through an angle R about the axis A. The gear514 may drive the toothed gear 518 and the outer cylinder 506 to rotatein either direction.

The shaft first 526 extending from and coupled to the gear 524 may berotated by a drive motor causing rotation of the gear 524. Rotation ofthe gear 524 may cause the toothed gear 520 of the inner cylinder 510 torotate the inner cylinder 510 around the axis A. The rotation of theinner cylinder 510 around the axis A may cause the threads 507 on theinner circumference of the inner cylinder 510 to interact with thethreads 512 of the sheath holder 502 to drive the sheath holder 502forward or backward a distance D along the axis A. Counter rotation ofthe inner cylinder 510 may be prevented by the pins 504 a and 504 binteracting with the sides of the grooves 514 a and 514 b.

In an embodiment, the anti-rotation feature of the pins 504 a and 504 bin the grooves 514 a and 514 b in combination with rotation (or positionlocking/holding) of the inner cylinder 510 and/or the outer cylinder 506may be used to control the rotation and extension of the sheath holder502 and an introducer coupled to an end 505 of the sheath holder 502(see FIG. 5A). As an example, the end 505 of the sheath holder 502 andan introducer coupled to the end 505 may be extended by causing theinner cylinder 510 to rotate. The rotation of the inner cylinder 510 andits threads 507 may impart a linear driving force on the threads 512 ofthe sheath holder 502. While the inner cylinder 510 is being rotated,such as to extend or retract the sheath holder 502, the outer cylinder506 including the pins 504 a and 504 b may be held stationary (forexample by holding the shaft 516 and gear 514 stationary). In thismanner, the pins 504 a and 504 b may interact with the sides of thegrooves 514 a and 514 b may prevent the rotation of the sheath holder502. By preventing the rotation of the sheath holder 502, the rotationalforce imparted from the rotating threads 507 of the inner cylinder 510on the threads 512 may be translated into a lateral force along the axisA to drive the sheath holder 502 out of the inner cylinder 510 or intothe inner cylinder 510. The pins 504 a and 504 b may be held stationaryrelative to the axis A as the sheath holder 502 extends and retracts andmay in turn prevent the sheath holder 502 from rotating or counterrotating. As the sheath holder 502 extends and retracts, the pins 504 aand 504 b may slide along the grooves 514 a and 514 b along the axis A.

In an embodiment, the distance D of the extension or retraction of thesheath holder 502 out of or into the inner cylinder along the axis A maybe governed by the length of the grooves 514 a and 514 b in the sheathholder 502.

In another example, the end 505 of the sheath holder 502 and anintroducer coupled to the end 505 may be caused to rotate by rotationthe outer cylinder 506. The rotation of the outer cylinder 506 mayrotate the pins 504 a and 504 b which may impart rotational force on thesides of the grooves 514 a and 514 b in the sheath holder 502, thusrotating the sheath holder 502 about the axis A. Because the outercylinder 506 and the inner cylinder 510 rotate together through theinteraction of the pins 504 a and 504 b on the grooves 514 a and 514 b,there is no relative movement between the threads 507 and the threads512. Therefore, the inner cylinder 510 (and the sheath holder 502) doesnot extend or retract. In other embodiments, to prevent the rotation ofthe outer cylinder 506 from causing the sheath holder 502 to be extendedand/or retracted based on the rotational engagement of the threads 507and the threads 512 of the inner cylinder 510, the inner cylinder 510may be deliberately rotated (for example by rotating shaft 526 to rotategear 524). In an embodiment, the sheath holder 502 may be rotated anyangle R in either direction around the axis A. In other embodiments, thesheath holder 503 may be rotated multiple revolutions around the axis A(e.g., greater than 360 degrees).

FIG. 6 illustrates an embodiment adjustable nose cone 600 with anintroducer support 620 that provides an alternative for rotating,extending and retracting an introducer and/or catheter body. Theintroducer support 620 may comprise a hollow cylinder 625 surrounded bya drive gear 624. The hollow cylinder 625 may extend past the front andback face of the drive gear 624 forming an axle that protrudes from thecenter of the drive gear 624. The hollow cylinder 625 may include afixed clasp or clamp receiving portion 626 a formed on one end. A claspor clamp 622 a may be rotated in order to couple to the fixed clampreceiving portion 626 a by a hinge 622 b. The clamp 622 a may be securedto the fixed clamp receiving portion 626 a by a friction coupling or aclip 622 c such that the clamp 622 a and fixed clamp receiving portion626 a may form a clamp to securely hold a throat 214 of the introducer208. In some embodiments, the fixed clamp receiving portion 626 a mayhave a series of teeth 626 b that may engage the clip 622 c in differentpositions. The clamp 622 a and the fixed clamp receiving portion 626 amay thereby be adjusted to provide a secure fit, such as to accommodatedifferent sizes of the throat 214 or to provide different degrees oftightness around the throat 214.

In an embodiment, the clasp 622 a and/or fixed clamp receiving portion626 a may each include a gap 622 d, 626 c to accommodate an irrigationport 210 of the introducer 208. The hollow cylinder 625 may beconfigured to enable a catheter body to pass through the hollow cylinder625, such as through a shaft 212 of the introducer 208, which is held inthe clamp of the introducer support 620.

The nose cone 600 may further include a guide 601 for receiving theintroducer support 620, which may have two supports 608 a and 608 b. Thesupports 608 a and 608 b may include semi-circular linkage supports 609a and 609 b, which may be configured to support an outer surface of thehollow cylinder 625 of the introducer support 620 when the introducersupport 620 is placed in the nose cone 600. The semicircular linkagesupports 609 a and 609 b may have tabs 609 c to provide a secure snapfit coupling for the introducer support 620. The arms of thesemicircular linkage supports 609 a and 609 b may be flexible such thatthe tabs 609 c provide a way of securing the introducer support 620,while allowing easy removal. The supports 608 a and 608 b may be spacedapart such that the drive gear 624 can rotate between the support 608 aand 608 b when the hollow cylinder 625 of the introducer support 620 isplaced in the supports 608 a and 608 b.

The nose cone 600 may include a splined shaft 606 driven by motor 602.The splined shaft 606 may pass through openings in the supports 608 aand 608 b. The introducer support 620 may be supported in the guide 601such that the teeth of the drive gear 624 may interface with the splinesof the splined shaft 606. Rotation of the motor 602 and the splinedshaft 606 may engage and rotate the drive gear 624 to rotate theintroducer support 620 and the introducer 208.

The guide 601 may be threaded onto a threaded shaft or a worm gear 610passing through threaded openings 601 a and 601 b in the supports 608 aand 608 b. The worm gear 610 may be driven by a motor 604. Rotation ofthe motor 604 and the worm gear 610 in different directions may causethe guide 601, the introducer support 620 and the introducer 208 toextend and retract.

Activation of the motor 602 to drive the splined shaft 606 may cause thedrive gear 624 to rotate, thereby causing the introducer 208 held in theintroducer support 620 to rotate allowing rotational positioning of theintroducer 208, and a catheter body. Activation of the motor 604 todrive the worm gear 610 may cause the guide 601 to travel along the wormgear 610, thereby causing the introducer 208 held by the removablelinkage 602 to extend or retract allowing positioning of the introducer208 and a catheter body along a linear axis.

In some embodiments, the introducer support 620 and the introducer 208secured within the introducer support 620 may be removed from the guide601 by lifting the introducer support 620 out of the guide 601, such asby pulling the introducer support 620 past the tabs 609 c. In thismanner, the introducer support 620 and introducer 208 may be removed asa single unit, thereby enabling a doctor to manipulate the introducersupport 620 and introducer 208 independent of a catheter positioningsystem.

FIG. 7 illustrates an alternate embodiment adjustable nose cone 700similar to nose cone 600 described above with reference to FIG. 6,except that the guide 701 of nose cone 700 may be formed from a singlemolded piece of material instead of separated supports 608 a and 608 b.An introducer support 720 may be provided to support the introducer 208.The introducer support 720 may include a drive gear 722 around at leasta portion of circumference. For example, the drive gear 722 may beformed in an approximate circular or “U” shape. The drive gear 722 mayhave a “U” shaped cut out 723 into which the introducer 208 may beinserted. The “U” shaped cut out 723 may extend from the outer surfaceof the drive gear 722 through the center of the drive gear 722 and theintroducer support 720. The bottom of the “U” shaped cut out 723 may beconfigured to support the throat 214 of the introducer 208. The open topof the “U” shaped cut out 723 may enable the irrigation port 210 toextend out of the drive gear 722 and introducer support 720.Additionally, a ridge 725 may extend from a front face of the drive gear722 and a ridge may extend from a back face of the drive gear 722 tosupport the drive gear 722 and the introducer support in the guide 701.

The introducer support 720 may include a fixed clamp portion 726 formedon one end, such as at the bottom of the “U” shaped cut out 723. Amovable clamp portion 724 a may be configured to rotate about a hinge724 b and couple to the fixed clamp portion 726. The clasp 724 may besecured to the fixed clamp portion 726 by friction or a clip such thatthe movable clamp portion 724 a and fixed clamp portion 726 may form aclamp to hold the throat 214 of the introducer 208 within the “U” shapedcut out 723.

The guide 701 of the nose cone 700 may be configured to support theintroducer support 720. As an example the ridge 725 of on the front faceof the drive gear 722 and the ridge on the back face of the drive gear722 may rest in curved cutouts 701 a in the walls of the guide 701. Theintroducer support 720 may be supported in the guide 701 such that theteeth of the drive gear 722 may interface with the splines of thesplined shaft 606 that extend through an interior of the guide 701 andare driven by the motor 602. Rotation of the motor 602 and the splinedshaft 606 may cause rotation of the drive gear 722 and the introducersupport 720, and in turn may cause rotation of the introducer 208. Theguide 701 may further be coupled to the worm gear 610 through a threadedopening 701 b that extends through the guide 701. The worm gear may berotated by the motor 604. Rotation of the motor 604 and the worm gear610 may cause linear movement of the guide 701 and corresponding linearmovement to extend or retract the introducer support 720 and theintroducer 208.

FIG. 8A and FIG. 8B illustrate two views of another embodimentadjustable nose cone 800. The embodiment nose cone 800 may be adjustableto enable the introducer 208 to be rotated through an angle R′ around anaxis A and/or to be extended or retracted a distance D′ along the axisA.

FIG. 8A presents a top perspective view of the nose cone 800 and areflection showing a bottom perspective view of the nose cone 800 in amirrored plane M. FIG. 8A illustrates the relationship of components onthe top of the nose cone 800 and the underside of the nose cone 800. Thenose cone 800 may include a support portion 801, a slide portion 802,and a hollow rotating portion 808. A first or proximal end 801 a of thesupport portion 801 may be configured to connect the nose cone 800 to acatheter positioning system, for example via snaps, clamps, and/or afriction connector. A second or distal end 801 b of the support portion801 may be configured to form a slide arm 803 extending along the axisA. The slide arm 803 may include one or more tabs 805 a, 805 bconfigured to fit within and travel along longitudinal slots 807 a, 807b formed in a surface of the slide portion 802. The tabs 805 a and 805 bmay secure the slide arm 803 to the slide portion 802. The tabs 805 aand 805 b may further help to ensure proper alignment when the slide arm803 is extended and retracted relative to the slide portion 802. Thelongitudinal slots 807 a, 807 b may have a length configured so that theone or more tabs 805 a, 805 b contact an end of the corresponding slotat a maximum extension distance D. The end of the slots 807 a and 807 bmay act as mechanical stops by preventing the slide arm 803 fromdisconnecting from slide portion 802, such as when fully extended orfully retracted.

In an embodiment, the support portion 801 and slide portion 802 may beconfigured to hold together at an established fixed extension distanceD. The slide portion 802 may be slidably attached to the slide arm 803and may be configured to slide over the slide arm 803 to extend orretract a distance D along the slide arm 803 and axis A. For example, alatching lever 804 may be provided on the slide portion 802. Thelatching lever 804 may operate to engage and disengage a tooth 806 fromribs 808 (shown in the reflection) formed in the bottom surface of theslide arm 803. The engagement of the tooth 806 of the latching lever 804with the one or more ribs 808 of the slide arm 803 may “lock” the slideportion 802 into a given position and may prevent the slide portion 802from further extending or retracting along the slide arm 803 and axis A.The latching lever 804 may be depressed to disengage the tooth 806 fromthe one or more ribs 803 to enable the slide portion 802 to slide overthe slide arm 803 to extend or retract a distance D along the slide arm803 and axis A. In some embodiments, the latching lever 804 may bemanually operated. In other embodiments, it may be possible for thelatching lever 804 to be operated automatically by pressure from anexternal mechanism (not shown).

The rotating portion 808 may be rotationally coupled to the slideportion 802 and configured to rotate through an angle R around the axisA. An end of the rotating portion 808 opposite the slide portion 802 mayinclude an introducer clamp 810 formed from a fixed clamp portion 810 band a clamp tab 810 a which may be coupled to the fixed clamp portion810 b by rotating about a hinge (not shown). Alternatively, the clamptab 810 a may be made from a flexible material that is self-hinging orthat may have a crease hinge or other type of hinge. The clamp tab 810 amay fasten to the fixed clamp portion 810 b by a friction connection,snap fit connection, interlocking tabs, and so on. The introducer clamp810 may fasten over a throat 214 of an introducer 208 to securely holdthe introducer 208 in place.

In an embodiment, the introducer clamp 810 may include one or morecutout 812 configured to enable the irrigation port 210 of theintroducer to pass through the fixed clamp portion 810 b and clamp tab810 a of the introducer clamp 810. While the cutout 812 is shown in thefixed clamp portion 810 b, a cutout 812 may alternatively be provided inthe clamp tab 810 a, or may be provided in both the clamp tab 810 a andthe fixed clamp portion 810 b.

In the illustrated embodiment, the slide portion 802 and slide arm 803may be formed as open troughs enabling direct access to the innerportions of the slide portion 802 and slide arm 803 from one or moresides of the slide portion 802 and slide arm 803, such as for placementof an introducer, catheter, or other component therein. In someembodiments, an introducer and catheter body or other components may bethreaded through the rotating portion 808. In an optional embodiment,the rotating portion 808 may include a slot 814 a and the slide portion802 may include a slot 814 b such that an introducer, catheter body orother components may be inserted from the top without threading. Therotating portion 808 may be rotated around the axis A to align the slot814 a with the slot 814 b, thereby enabling the body of a catheter to beinserted from above such as by passing through the outer surface of therotating portion 808 and into the center of the rotating portion 808 andthe center of the troughs of the slide portion 802 and slide arm 803.

FIG. 8B illustrates another view of the nose cone 800 with theintroducer 208 placed in the introducer clamp 810 of the rotatingportion 808. A catheter body may pass through the slide arm 803, theslide portion 802, the rotating portion 808, the clamp 810, and theintroducer 208, such as when the components of the nose cone 800 andintroducer 208 are coupled together.

In an embodiment, the rotating portion 808 may be rotated through anangle R around the axis A causing a corresponding rotation to beimparted to the shaft 212 of the introducer 208. The shaft 212 maythereby be rotated a distance R in a direction R′ around the axis A.

By providing a sliding connection between the slide portion 802 and theslide arm 803, the shaft 212 of the introducer 208 can be extended orretracted. For example, the shaft 212 may be extended or retracted adistance D′ along the axis A by sliding the slide portion 802 a distanceD along the slide arm 803. In this manner, the nose cone 800 may beextended, retracted and rotated to various angles. The nose cone 800 maybe repositioned relative to the patient (and/or moved into and out ofthe patient) over a range of distances to direct the shaft 212 of theintroducer 208 and/or a shaft of a catheter passed through the nose cone800 and introducer 208 in a particular direction and/or to a particularspot within the patient.

As described above, the programmable control system 132 may beconfigured with processor-executable instructions to issue drive orpower commands to each of the motors in the catheter positioning system,including the drive motors within or coupled to the introducer orintroducer support, such as a motor coupled to the shafts 516, 526extending from and driving the gears 514, 524 described above withreference to FIG. 5C, the motors 602, 604 driving the splined shaft 606and the worm gear 610, described above with reference to FIG. 6 and FIG.7, and so on.

Those skilled in the art will recognize that the methods and systems ofthe present invention have many applications, may be implemented in manymanners and, as such, is not to be limited by the preceding exemplaryembodiments and examples. Additionally, the functionality of thecomponents of the preceding embodiments may be implemented in differentmanners. Further, it is to be understood that the steps in theembodiments may be performed in any suitable order, combined into fewersteps or divided into more steps. Thus, the scope of the presentinvention covers conventionally known and future developed variationsand modifications to the system components described herein, as would beunderstood by those skilled in the art.

What is claimed is:
 1. A introducer support configured for supporting anintroducer for a catheter positioning system, comprising: a hollow innercylindrical body having an attachment end configured to be secured in anose cone of the catheter positioning system; and a hollow outercylindrical body encircling the inner cylindrical body, an end of theouter cylindrical body opposite the attachment end comprising a clampconfigured to hold an introducer, wherein: the outer cylindrical body isslidably configured to rotate around the inner cylindrical body torotate the clamp around an axis of the introducer support; and the outercylindrical body is slidably configured to slide along the innercylindrical body to extend or retract the clamp along the axis of theintroducer support.
 2. The introducer support of claim 1, wherein theclamp includes a cutout configured to accommodate an irrigation port ofthe introducer.
 3. The introducer support of claim 2, wherein the outercylindrical body is configured to slide along the inner cylindrical bodyto extend the clamp along the axis of the introducer support a distancebetween 1 and 2 inches.
 4. The introducer support of claim 2, whereinthe outer cylindrical body includes a flexible portion coupled betweenthe introducer and the outer cylindrical body, the flexible portionconfigured to absorb energy transfer between the introducer and theouter cylindrical body.
 5. The introducer support of claim 4, whereinthe flexible portion comprises one or more bellows formed in the outercylindrical body.
 6. The introducer support of claim 4, wherein theflexible portion is configured to absorb one or more of a tensile forceand a torsional force.